NCT01770197

Brief Summary

The time window for intravenous recombinant tissue plasminogen activator treatment in ischemic stroke patients has been extended to 4.5h. Little is known about intravenous recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese stroke patients. This exploratory study was to describe the feasibility and outcome of treatment with intravenous recombinant tissue plasminogen activator in the expanded time window, and to offer suggestions for future clinical work in China.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

6.9 years

First QC Date

January 8, 2013

Last Update Submit

December 9, 2014

Conditions

Stroke

Keywords

ChinaStrokeThrombolytic therapy

Outcome Measures

Primary Outcomes (1)

  • National Institute of Health Stroke Scale score and modified Rankin Scale

    Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up

    Outcome measure will be assessed at 24 weeks

Study Arms (2)

recombinant tissue plasminogen activator

Stroke patients with rt-PA treatment in the 3-4.5 hour time window were compared with those within 3h.

Drug: IV rt-PA

rt-PA

One group of was treated with standard recombinant tissue plasminogen activator therapy in 3h and the other group of stroke patients was treated within 3-4.5h.

Drug: IV rt-PA

Interventions

IV rt-PADRUG

IV rt-PA treatment

Also known as: rt-PA
recombinant tissue plasminogen activatorrt-PA

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

stroke patients in the 3-4.5 hour time window

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Wuhan G H, High

    Wuhan General Hospital of Guangzhou Command

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
24 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wuhan General Hospital of Guangzhou Military Command

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 17, 2013

Study Start

January 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 10, 2014

Record last verified: 2014-12